Knee Osteoarthritis
Conditions
Keywords
KOA, Osteoarthritis, Knee, Sodium Hyaluronate, WOMAC, VAS, KOOS
Brief summary
Double-blind study assessing the safety and efficacy of TrHCROSS® in knee osteoarthritis, compared to Hyalone®, using scales such as WOMAC, VAS, and KOOS. The population includes 60 symptomatic patients with mild to moderate KOA (Kellgren-Lawrence II or III) who have not responded adequately to non-pharmacological treatments or simple analgesics.
Interventions
DEVICETrHCROSS®
Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked.
DEVICEHyalone®
Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked
Sponsors
Hospital Universitario Araba
Bioaraba
i+Med S.Coop.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Non-inferiority, controlled, interventional, randomized, parallel-group, single-blind, and single-center clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men or women between 18 and 80 years of age. * Body mass index \<40 kg/m². * Diagnosis of knee osteoarthritis (KOA). The stage must be radiographically confirmed (Kellgren-Lawrence grade II or III) within 6 months prior to study entry. * Persistent pain reported during the 3 months prior to recruitment and moderate to severe pain when walking on inclines or stairs, or at rest (VAS score ≥40) at baseline. * History of analgesic use (paracetamol and/or NSAIDs) related to the study condition. * Willingness and ability to complete questionnaires and understand study instructions. * Signed informed consent specific to the study.
Exclusion criteria
* X-rays showing grade IV changes on the Kellgren-Lawrence scale. * Severe functional impairment in the knee. * Bilateral involvement (simultaneous involvement of both knees). * Associated hip osteoarthritis. * Clinically significant pain in joints other than the knee. * Psoriasis. * Patients with confirmed rheumatic joint disease. * Active infection. * Known or suspected use of intra-articular steroids within the previous 3 months, or intra-articular HA or PRP within the 9 months prior to treatment initiation, as well as the use of chondroprotective agents. * Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of TrHCROSS® for pain relief in patients with KOA. | In 24 weeks. | Comparison of TrHCROSS® with Hyalone®, with significant improvement considered if there was a change of ≥50% and ≥5 points in the WOMAC A pain score. The WOMAC A questionnaire is divided into five items to measure pain, with a scoring range from 0 to 20, where 0 represents the least amount of pain and 20 represents the most intense pain. |
| Serious adverse events. | Through study completion, approximately 52 weeks. | Evaluate the safety of the treatment, in terms of the incidence of serious adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functionality using WOMAC C. | In 24 weeks and in 52 weeks. | Evaluate the effectiveness of TrHCROSS® in improving functionality at 24 and 52 weeks using the WOMAC C functionality score, and compare it with Hyalone®. The WOMAC C questionnaire has a scoring range from 0 to 68, where a lower score indicates less difficulty and a higher score indicates greater difficulty. |
| Global Patient Assessment. | In 24 weeks and in 52 weeks. | Analyze the global patient assessment after administration of the study treatment with VAS and compare it with the one obtained after administration of Hyalone®. The Visual Analogue Scale (VAS) allows for the assessment of the patient's overall evaluation, ranging from 0 to 100 mm, with 0 indicating the best outcome and 100 the worst outcome. |
| Combined WOMAC and VAS scales. | At baseline, in 24 weeks and in 52 weeks. | Evaluate the combined WOMAC and VAS scales from baseline at all follow-up visits (weeks 24 and 52). The VAS is measured in mm (from 0 to 100), while the WOMAC uses a Likert scale to provide a total score. |
| Improvement in pain score. | At baseline, in 24 weeks and in 52 weeks. | Analyze the improvement in pain scores (WOMAC A) from baseline (at least 40% and ≥5 points) in each treatment group separately. The WOMAC A questionnaire consists of five items to assess pain, with a scoring range from 0 to 20, where 0 indicates minimal pain and 20 represents the most severe pain. |
| Improvement in KOOS scores. | At baseline, in 24 weeks and in 52 weeks. | Analyze the significant improvement in KOOS scores from baseline in each treatment group separately. The KOOS scale is divided into subscales that are scored individually: Pain, Other Symptoms, Daily Activities, Function, Sports/Recreational Activities, and Quality of Life. A Likert scale is used, and all items have five possible options ranging from 0 (No problems) to 4 (Extreme problems). Each of the five scores is calculated as the sum of the items included |
| Pain relief using WOMAC A. | At the conclusion of the study, approximately 52 weeks later. | Evaluate the effectiveness of TrHCROSS® in pain relief at 52 weeks using the WOMAC A pain score, and compare it with Hyalone®. The WOMAC A questionnaire consists of five items to assess pain, with a scoring range from 0 to 20, where 0 indicates minimal pain and 20 represents the most severe pain. |
| Patient satisfaction with treatment. | At the conclusion of the study, approximately 52 weeks later. | Evaluate patient satisfaction with the treatment using a Likert scale with 5 options: Very satisfied, Satisfied, Slightly satisfied, Indifferent, and Dissatisfied. The percentage of patients who rate their satisfaction as 'Very satisfied,' 'Satisfied,' and 'Slightly satisfied' will be calculated. |
| Other adverse events. | Through study completion, approximately 52 weeks. | Analyze and record the incidence of other adverse events to ensure it does not exceed the pre-established threshold of 18%. |
| Analgesic use. | Through study completion, approximately 52 weeks. | Monitor the need for analgesic use. |
| Joint mobility. | At baseline, in 24 weeks and in 52 weeks. | Evaluate joint mobility by measuring the joint range with a goniometer and assess its progression from baseline to the follow-up visits. |
| Investigator´s global assessment. | At the conclusion of the study, approximately 52 weeks later. | For the overall treatment evaluation by the investigator, a Likert scale with 5 options will be used: Significant improvement, Improvement, Slight improvement, No change, and Worsening. Patients classified by the investigator as having a perceived global change after treatment of 'slight improvement,' 'improvement,' or 'significant improvement' will be identified as having a clinically relevant improvement. |
| Treatment response rate. | At baseline, in 24 weeks and in 52 weeks. | Calculate the treatment response rate at all follow-up visits (weeks 24 and 52) according to the OMERACT-OARSI criteria and compare it with Hyalone®. A responder is defined as having at least a 50% improvement and an absolute change of ≥20mm in pain or functionality, or improvement in two of the three subscales with ≥20% and ≥10mm change in the VAS scales for pain, functionality, and overall patient evaluation. |
| Stiffness using WOMAC B. | In 24 weeks and in 52 weeks. | Assess the effectiveness of TrHCROSS® in reducing stiffness at 24 and 52 weeks using the WOMAC B stiffness score, and compare it with Hyalone®. The WOMAC B questionnaire ranges from 0 to 8, where a lower score reflects less stiffness and a higher score indicates more severe stiffness. |
Countries
Spain
Outcome results
None listed